Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 27921–27940 of 38,428 recalls
Recalled Item: LightSpeed Ultra (8-slice MDAS)
The Issue: GE Healthcare has updated the Service Manuals for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percutaneous Insertion Tray
The Issue: The sheath body may become separated from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery LS
The Issue: GE Healthcare has updated the Service Manuals for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultra 8 IAB: 8Fr 40cc
The Issue: The sheath body may become separated from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LightSpeed 16 (MDAS only
The Issue: GE Healthcare has updated the Service Manuals for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery ST
The Issue: GE Healthcare has updated the Service Manuals for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultra 8 IAB: 8Fr 30cc
The Issue: The sheath body may become separated from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System -
The Issue: GE Healthcare has updated the Service Manuals for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RediGuard IAB: 7Fr 30cc
The Issue: The sheath body may become separated from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UltraFlex IAB: 7.5Fr 30cc
The Issue: The sheath body may become separated from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is
The Issue: The sheath body may become separated from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System -
The Issue: GE Healthcare has updated the Service Manuals for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UltraFlex IAB: 7.5Fr 40cc
The Issue: The sheath body may become separated from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percutaneous Insertion Tray
The Issue: The sheath body may become separated from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FiberOptix Ultra 8 IAB: 8Fr 40cc
The Issue: The sheath body may become separated from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Cardio software. The firm name on the label is Merge Healthcare
The Issue: A report can be confirmed with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension clinical chemistry system
The Issue: Siemens Healthcare Diagnostics has received customer complaints regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic
The Issue: Medtronic Neuromodulation is initiating a voluntary removal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F
The Issue: Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J
The Issue: Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.